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接受手术的肺癌患者的精确运动处方:PEP 研究 (PEP)

2026年5月13日 更新者:University of Utah

比较个性化锻炼计划 (PEP) 与不干预对接受手术切除的 I-IIIa 期原发性非小细胞肺癌或继发性肺癌患者影响的 III 期随机研究

这是一项 3 期研究,旨在调查个性化锻炼计划 (PEP) 对在犹他大学接受手术治疗的 NSCLC 患者(I、II、IIIa 期)和继发性肺癌患者的影响,并将干预措施与目前的干预措施进行比较护理标准(无锻炼计划)。

研究概览

详细说明

这是一项 3 期研究,旨在调查个性化锻炼计划 (PEP) 对在犹他大学接受手术治疗的 NSCLC 患者(I、II、IIIa 期)和继发性肺癌患者的影响,并将干预措施与目前的干预措施进行比较护理标准(无锻炼计划)。

符合条件的患者将在手术前随机分配到两组(1:1 的比例),并在手术后接受大约 6 个月的随访:

  • 干预组(在材料中称为第 1 组),其特点是手术前和手术后 PEP 干预。
  • 不包括个性化锻炼计划(护理标准)的控制臂(在材料中称为第 2 组)。 随机分配到控制组的患者将有机会参加 PEP 干预会议,在 6 个月评估后提供运动咨询,并将获得免费的活动跟踪器。

研究类型

介入性

注册 (实际的)

182

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Utah
      • Salt Lake City、Utah、美国、84112
        • Huntsman Cancer Institute

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

描述

纳入标准:

  • 年龄≥ 18 岁的男性或女性受试者。
  • 原发性肺癌 I、II 或 IIIa 期或继发性肺癌的诊断。
  • 治疗外科医生认为适合手术切除的疾病。
  • 患者必须能够遵循指示并用英语完成问卷调查和运动日记。
  • 患者必须同意被随机分配到干预组或对照组。

排除标准:

  • 被登记医师认为不适合手术
  • 由研究医师或监督物理治疗师判断的筛选体检异常,禁止参与锻炼计划依从性。
  • 由研究医师判断的酒精或药物滥用。
  • NCCN 痛苦温度计将评估会影响研究参与的重大精神或情绪问题。 任何高于 7 的值都会触发进一步的干预,但最终是否参加临床试验将由登记医师决定。

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:个性化锻炼计划

PEP 干预包括家庭锻炼和住院锻炼的结合。 锻炼模式将包括基本的转移和健美操运动、有氧运动和阻力运动,并将以各种姿势(仰卧、坐着、站立和行走)进行,挑战各异(水平行走、弯曲、倾斜、台阶和蹲下)。

对于随机分配到干预组(第 1 组)的患者,PEP 干预将由有执照的物理治疗师通过面对面、虚拟或电话进行个性化、实施和修改(根据患者的 AM-PAC 活动阶段)会议(约 30-40 分钟)。 物理治疗师将使用专门为这项研究开发的运动教育手册来教育患者开始和维持运动干预的各个方面。

无干预:护理标准 - 无运动

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Mobility Performance - Six Minute Walk (6MW) Distance
大体时间:Hospital Discharge (up to 38 days after the initiation of the study therapy), 2-Month Post Surgery Visit (up to 5 months after the initiation of the study therapy), and 6-Month Post Surgery Visit (up to 9 months after the initiation of study therapy)
Six Minute Walk (6MW) distance is the distance patients can walk indoors on a 25-meter level, smooth-surfaced track over the course of 6 minutes. This outcome will report the mean 6MW distance at hospital discharge (up to 38 days after the initiation of the study intervention), at the 2-Month Post Surgery Visit (up to 5 months from the initiation of the study intervention), and at the 6-Month Post Surgery Visit (up to 9 months from the initiation of the study intervention).
Hospital Discharge (up to 38 days after the initiation of the study therapy), 2-Month Post Surgery Visit (up to 5 months after the initiation of the study therapy), and 6-Month Post Surgery Visit (up to 9 months after the initiation of study therapy)

次要结果测量

结果测量
措施说明
大体时间
Evaluate the Change Short Physical Performance Battery (SPPB) Score
大体时间:Hospital Discharge (up to 38 days after the initiation of the study therapy), 2-Month Post Surgery Visit (up to 5 months after the initiation of the study therapy), and 6-Month Post Surgery Visit (up to 9 months after the initiation of study therapy)

This outcome will report the results from the Short Physical Performance Battery (SPPB).

This secondary outcome measure is associated with the evaluation of improvement in physical performance is the result of the short physical performance battery test. The SPPB score (ranging from 0 to 12) will be obtained for each patient at the time points described above. A score of 0 indicates the worst performance, and a score of 12 indicates the best performance.

This outcome will report median SPPB scores at hospital discharge (up to 38 days after the initiation of the study intervention), at the 2-Month Post Surgery Visit (up to 5 months from the initiation of the study intervention), and at the 6-Month Post Surgery Visit (up to 9 months from the initiation of the study intervention).

Hospital Discharge (up to 38 days after the initiation of the study therapy), 2-Month Post Surgery Visit (up to 5 months after the initiation of the study therapy), and 6-Month Post Surgery Visit (up to 9 months after the initiation of study therapy)
FACT-L (Functional Assessment of Cancer Therapy-Lung) Questionnaire
大体时间:Hospital Discharge (up to 38 days after the initiation of the study therapy), 2-Month Post Surgery Visit (up to 5 months after the initiation of the study therapy), and 6-Month Post Surgery Visit (up to 9 months after the initiation of the study therapy)

The FACT-L (Functional Assessment of Cancer Therapy-Lung) questionnaire assesses health-related quality of life (QOL). Total scores range from 0-136, with lower scores representing worse QOL and higher scores representing better QOL.

This outcome measure will report mean FACT-L total scores at Hospital Discharge (up to 38 days after the initiation of the study therapy), 2-Month Post Surgery Visit (up to 5 months after the initiation of the study therapy), and 6-Month Post Surgery Visit (up to 9 months after the initiation of the study therapy).

Hospital Discharge (up to 38 days after the initiation of the study therapy), 2-Month Post Surgery Visit (up to 5 months after the initiation of the study therapy), and 6-Month Post Surgery Visit (up to 9 months after the initiation of the study therapy)
Fatigue Subscale (FS)
大体时间:Hospital Discharge (up to 38 days after the initiation of the study therapy), 2-Month Post Surgery Visit (up to 5 months after the initiation of the study therapy), and 6-Month Post Surgery Visit (up to 9 months after the initiation of study therapy)

This outcome will report the results of the Fatigue Subscale (FS) from the FACIT-F (Chronic Illness Fatigue Scale) questionnaire. The FACIT-F is a self-reported evaluation of fatigue in cancer patients. This questionnaire has patients rank statements regarding physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns from 0 Not at All to 4 Very Much.

This outcome will report the FS score from the FACIT-F. The FS has a minimum of 0 and a maximum of 52; the higher the score the better the Quality of Life (QOL). The FS Score is calculated from 13 survey items. Individual items that were "reverse items" (meaning a high value indicates poor QOL) were subtracted from 4. Then all "reverse items" and normal items were added together to calculate the FS score.

This assessment was scored according to the FACIT-F Scoring Guidelines (Version 4).

Hospital Discharge (up to 38 days after the initiation of the study therapy), 2-Month Post Surgery Visit (up to 5 months after the initiation of the study therapy), and 6-Month Post Surgery Visit (up to 9 months after the initiation of study therapy)
BREQ-3 (Behavioral Regulation in Exercise Questionnaire 3) Questionnaire
大体时间:Hospital Discharge (up to 38 days after the initiation of the study therapy), 2-Month Post Surgery Visit (up to 5 months after the initiation of the study therapy), and 6-Month Post Surgery Visit (up to 9 months after the initiation of study therapy)

This outcome will report the results of the BREQ-3. The questionnaire has 24 items, each item ranging from 0 "Not True for Me" to 4 "Very True for Me".

This questionnaire will report 6 sub-scores, Amotivation, External Regulation, Introjected Regulation, Identified Regulation, Integrated Regulation, Intrinsic Regulation.

Each sub score is a the average of 4 items, ranging from 0-4 with higher values indicating higher motivation.

Hospital Discharge (up to 38 days after the initiation of the study therapy), 2-Month Post Surgery Visit (up to 5 months after the initiation of the study therapy), and 6-Month Post Surgery Visit (up to 9 months after the initiation of study therapy)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年11月7日

初级完成 (实际的)

2022年5月31日

研究完成 (实际的)

2022年5月31日

研究注册日期

首次提交

2017年9月29日

首先提交符合 QC 标准的

2017年10月5日

首次发布 (实际的)

2017年10月11日

研究记录更新

最后更新发布 (实际的)

2026年6月9日

上次提交的符合 QC 标准的更新

2026年5月13日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • HCI104671
  • 5R01CA211705-05 (美国 NIH 拨款/合同)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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非小细胞肺癌的临床试验

个性化锻炼计划的临床试验

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